Acetaminophen alone versus acetaminophen plus ibuprofen for pain after cesarean delivery
Official title: Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
Run by Seoul National University Hospital · NCT06479122 · Data updated 2026-11-12
This will see if adding intravenous ibuprofen to IV acetaminophen gives better pain relief than acetaminophen alone for people after an elective cesarean delivery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | Women only |
| Enrollment | 84 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | October 9, 2024 |
| Main results expected | June 25, 2026 |
| Study ends | August 25, 2026 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT06479122 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people having an elective cesarean at term (≥37+0 weeks), meeting weight and organ-function criteria and without contraindications to acetaminophen or ibuprofen.
✕Probably not a fit
People with contraindications such as NSAID or acetaminophen allergy, liver or kidney disease, peptic ulcer/upper GI bleeding, asthma related to NSAIDs, multiple pregnancy, low body weight, or those undergoing emergency cesarean are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4 interventional study compares IV acetaminophen alone to a combined IV acetaminophen/ibuprofen product (Maxigesic® IV) given as part of multimodal analgesia after elective cesarean section. Participants scheduled for term elective cesarean (≥37 weeks) will receive one of the two analgesic regimens and have postoperative pain scores and analgesic use recorded. The trial is conducted at a single center, Seoul National University Hospital, with standard perioperative care otherwise unchanged. Key exclusions include emergency cesarean, multiple pregnancy, significant liver or kidney disease, NSAID or acetaminophen hypersensitivity, and other contraindications listed in the protocol.
Why it matters
Potential benefit: If successful, the combination regimen could provide better postoperative pain control and reduce opioid requirements after cesarean delivery.
How similar studies have gone: Previous randomized trials have shown that combining acetaminophen (paracetamol) with ibuprofen improves postoperative pain control and reduces opioid use compared with acetaminophen alone, so this approach is supported by prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective cesarean section * Gestational age \> 37+0 weeks Exclusion Criteria: * Emergency cesarean section * Multiple pregnancy (e.g. twins, triplets) * Body weight \< 50 kg * Preeclampsia * History of hypersensitivity to acetaminophen or ibuprofen * History of upper gastrointestinal tract bleeding or gastric ulcer * Underlying liver disease * Underlying kidney disease or GFR \< 90 mL/min/1.73m2 * Heart failure or severe hypertension * History of asthma * Chronic use of barbital or tricyclic antidepressants
Where it's running
-
Seoul National University Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Hansol Kim, MD
- Email: hansolfrkr@gmail.com
- Phone: +82-10-3160-1548
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.